Principal Project Data Manager

September 27

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Allucent

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Drug Development • Regulatory Affairs and Submissions • Clinical Strategy • Cell & Gene Therapy • Rare Diseases & Orphan Indications

1001 - 5000

Description

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials. • We are looking for a Principal Project Data Manager (PrPDM) to join our A-team. • Responsible for leading, coordinating and overseeing data management activities, timelines and project finances. • This position manages and coordinates DM deliverables throughout the clinical data lifecycle. • Takes responsibility for the overall coordination and management of Biometrics standalone projects. • Provides leadership and is a Subject Matter Expert (SME) in relevant data management areas. • Responsible for the identification, qualification, and management of vendors as required for project delivery. • Actively support to staff learning & development within the company.

Requirements

• Life science, healthcare degree and/or combination of education and experience • Minimum 12 years or relevant work experience in Clinical Data Management or related experience within Biometrics. • Minimum 4 years of experience at Project Data Manager level (or equivalent) • Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements • Good understanding of Medical Terminology • Experience as DM lead on several studies and experience in covering all phases of a clinical study (start up, conduct and database lock). Worked on multiple indications and clinical phases (I-IV) • Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation • Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models • Client management experience • Experience in developing data management standards • Excellent written and verbal communication skills including good command of English language • Representative, outgoing and client focused • Ability to work in a fast-paced challenging environment of a growing company • Proficiency with various computer applications such as Word, Excel, and PowerPoint required • Administrative excellence • Attention to detail, strong technical, analytical and problem-solving skills • Excellent project management skills • Ability to translate guidelines, rules and regulations in clear and usable recommendations • Ability to simplify complex issues into understandable concepts • Excellent organizational, negotiating, motivational and influential skills

Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/hybrid* working depending on location • Leadership and mentoring opportunities • Participation in our enriching Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees